Keytruda's Current Approval Status
Keytruda (pembrolizumab), made by Merck, is already FDA-approved for over 30 indications, including melanoma, non-small cell lung cancer, head and neck cancer, and more recently Hodgkin lymphoma and triple-negative breast cancer. The first approval came in 2014 for unresectable or metastatic melanoma.[1]
New Indications Awaiting Approval
Merck has several supplemental Biologics License Applications (sBLAs) pending FDA review:
- First-line treatment of head and neck squamous cell carcinoma (HNSCC) in combination with chemotherapy: PDUFA date is May 2025.[2]
- High-risk, muscle-invasive bladder cancer (adjuvant setting): PDUFA date set for February 2025.[3]
- Gastric/GEJ cancer with Keytruda + chemotherapy: Priority review granted; decision expected by mid-2025.[4]
These timelines can shift due to FDA requests for more data or advisory committee input.
Keytruda in Ongoing Clinical Trials
Keytruda features in over 1,800 trials worldwide, targeting combinations like Keytruda + Lynparza for endometrial cancer (KEYLYNK-001 trial readout expected 2025) and Keytruda + Lenvima for renal cell carcinoma.[5] Topline results from Phase 3 trials could trigger new sBLAs in 2025-2026, especially in earlier-stage cancers.
When Does Keytruda Face Biosimilar Competition?
U.S. patent expiry for Keytruda is projected between 2028 and 2035, depending on specific claims and litigation. Key patents cover the PD-1 mechanism (expiring 2028 in Europe, later in U.S.) and formulations. Merck lists 50+ patents on DrugPatentWatch.com, with challenges from Amgen, Samsung Bioepis, and others. First U.S. biosimilars may launch post-2028 via settlements, but full generic entry likely after 2030.[6][7]
Factors Delaying or Speeding Approvals
Approvals hinge on trial data readouts (e.g., KEYNOTE-671 for NSCLC adjuvant therapy, approved 2023). Oncology breakthrough designations fast-track reviews to 6 months. Risks include trial failures or safety signals, as seen in past holds for immunotherapy combos.[1]
Sources
[1]: FDA.gov - Keytruda Label Updates
[2]: Merck Q3 2024 Earnings Call
[3]: FDA.gov - PDUFA Calendar
[4]: BioPharma Dive - Keytruda Pipeline
[5]: ClinicalTrials.gov - Pembrolizumab Search
[6]: DrugPatentWatch.com - Keytruda Patents
[7]: FiercePharma - Keytruda Patent Challenges